Scheduled and unscheduled bleeding patterns with two combined hormonal contraceptives: application of new recommendations for standardization.
OBJECTIVE
To reassess and compare cycle control attained with two combined hormonal contraceptives, norgestimate (NGM)/ethinyl estradiol (EE) 25 microg and norethindrone acetate (NETA)/EE 20 microg, by new general criteria recommendations for all combined hormonal contraceptives.


METHODS
Analysis of bleeding data for cycles 1-6 from a randomized, multicenter trial.


METHODS
221 North American centers.


METHODS
Healthy, sexually active women (18-45 years old).


METHODS
NETA/EE: 1 mg NETA/20 microg EE, days 1-21 of each cycle and 75 mg of ferrous fumarate, days 22-28; NGM/EE: triphasic NGM in 7-day increments (days 1-7: 180 microg; days 8-14: 215 microg; days 15-21: 250 microg) and 25 microg EE, placebo on days 22-28.


METHODS
Cycle control evaluated from patients' daily diaries.


RESULTS
For cycles 1-6, there was a statistically significant lower incidence of unscheduled bleeding/spotting with NGM/EE 25 microg (range 21.0%-34.4%) than with NETA/EE 20 microg (range 33.0%-46.6%). Of the women who had unscheduled bleeding/spotting, the mean number of days per cycle of bleeding/spotting was comparable. A statistically significant higher incidence of scheduled bleeding was seen with NGM/EE 25 microg (95.2%-97.5%) than with NETA/EE 20 microg (78.5%-84.2%).


CONCLUSIONS
The NGM/EE 25 microg has a lower incidence and comparable length of unscheduled bleeding and a higher incidence of scheduled bleeding than NETA/EE 20 microg in this post hoc analysis.
Hampton
Raymond Moss
RM
Texas Tech University School of Medicine, Odessa, Texas, USA.
Fisher
Alan C
AC
Pagano
Susan
S
LaGuardia
Katherine D
KD
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003267:Contraception / Q000592:standards*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects*; D009644:Norgestrel / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives; D010349:Patient Compliance; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014592:Uterine Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis; D055815:Young Adult
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C109079:norgestimate, ethinyl estradiol drug combination; C020416:norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D009640:Norethindrone